Actively Recruiting
REtreatment With VEnetoclax and Acalabrutinib After Venetoclax Limited Duration (REVEAL)
Led by Stichting Hemato-Oncologie voor Volwassenen Nederland · Updated on 2026-01-06
60
Participants Needed
18
Research Sites
623 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Fixed-duration regimens containing combinations of venetoclax with CD20 targeting agents are expected to soon become standard practice in first-line patients with chronic lymfocytic leukemia (CLL). The advantage of a fixed duration venetoclax combination as part of first-line treatment is the potential to retreat with venetoclax in patients who develop relapsed disease after a treatment free period. However, efficacy of venetoclax retreatment following a fixed duration venetoclax combination is still hypothetical as clinical data are lacking. Thus, there is an urgent need for data proving efficacy of venetoclax combinations following venetoclax treatment cessation. Testing of a novel venetoclax-containing regimen for relapsed CLL without the repeat of anti-CD20 monoclonal antibody (mAb) is a rational approach.
CONDITIONS
Official Title
REtreatment With VEnetoclax and Acalabrutinib After Venetoclax Limited Duration (REVEAL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented CLL or SLL requiring treatment according to IWCLL criteria after at least partial response to first-line venetoclax-rituximab or venetoclax-obinutuzumab treatment
- WHO/ECOG performance status between 0 and 3, stage 3 only if due to CLL
- Age 18 years or older
- Adequate bone marrow function with hemoglobin above 8 g/dL, neutrophil count above 750/µL unless due to CLL infiltration, and platelet count above 30,000/µL without transfusion
- Estimated kidney function with eGFR or creatinine clearance of 30 ml/min or higher
- Adequate liver function with specified limits for ASAT, ALAT, and bilirubin
- Prothrombin time and aPTT less than 1.5 times upper limit of normal
- Negative hepatitis B surface antigen and core antibody tests and negative hepatitis C antibody test or negative PCR if positive
- Ability and willingness to follow study visits and protocol
- Capable of giving informed consent
- Provided written informed consent
You will not qualify if you...
- Prior treatment with BTK inhibitors
- Previous venetoclax therapy other than first-line treatment
- Treatments other than allowed chemo-/immunotherapy after first-line venetoclax relapse
- Transformation of CLL (Richter's transformation)
- History of progressive multifocal leukoencephalopathy (PML)
- Other cancers requiring systemic therapy or showing progression
- Allergy to xanthine oxidase inhibitors or rasburicase
- Drug-specific hypersensitivity or anaphylaxis to study drugs
- Active bleeding disorders or bleeding history
- Active infections requiring systemic therapy
- Severe uncontrolled medical conditions (e.g., infections, autoimmune diseases, diabetes, thyroid disorders)
- Known HIV infection
- Use of strong CYP3A inhibitors/inducers or certain anticoagulants
- Recent stroke or intracranial hemorrhage within 6 months
- Severe heart, lung, neurological, or psychiatric diseases
- Difficulty swallowing or significant gastrointestinal disease
- Live vaccinations within 28 days prior
- Other experimental therapies within 28 days prior
- Major surgery within 28 days prior
- Recent steroid therapy except specified exceptions
- Pregnant or breastfeeding women
- Fertile men or women of childbearing potential without effective contraception
- Participation in other clinical trials except specified follow-up
- Conditions hampering compliance with study protocol or follow-up schedule
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
BE-Bruxelles-STLUC
Brussels, Belgium
Actively Recruiting
2
BE-Leuven-UZLEUVEN
Leuven, Belgium
Actively Recruiting
3
DK-Aarhus N-AUH
Aarhus, Denmark
Actively Recruiting
4
NL-Den Bosch-JBZ
's-Hertogenbosch, Netherlands
Actively Recruiting
5
NL-Amsterdam-AMC
Amsterdam, Netherlands
Actively Recruiting
6
NL-Arnhem-RIJNSTATE
Arnhem, Netherlands
Actively Recruiting
7
NL-Breda-AMPHIA
Breda, Netherlands
Actively Recruiting
8
NL-Delft-RDGG
Delft, Netherlands
Actively Recruiting
9
NL-Dordrecht-ASZ
Dordrecht, Netherlands
Actively Recruiting
10
NL-Ede-ZGV
Ede, Netherlands
Actively Recruiting
11
NL-Eindhoven-MAXIMAMC
Eindhoven, Netherlands
Actively Recruiting
12
NL-Groningen-UMCG
Groningen, Netherlands
Actively Recruiting
13
NL-Leeuwarden-MCL
Leeuwarden, Netherlands
Actively Recruiting
14
NL-Maastricht-MUMC
Maastricht, Netherlands
Actively Recruiting
15
NL-Nieuwegein-ANTONIUS
Nieuwegein, Netherlands
Actively Recruiting
16
NL-Rotterdam-IKAZIA
Rotterdam, Netherlands
Actively Recruiting
17
NL-Rotterdam-MAASSTADZIEKENHUIS
Rotterdam, Netherlands
Actively Recruiting
18
NL-Utrecht-UMCUTRECHT
Utrecht, Netherlands
Actively Recruiting
Research Team
A
A. Kater
CONTACT
H
H. Visser
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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